COMPANY OVERVIEW

• SpectronRx is a rapidly growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, IN, with additional locations in South Bend and Bunker Hill, IN, Danbury, CT and Europe. We are seeking an experienced Site QA Supervisor to join our growing company at our Indianapolis, IN site. The Site QA Supervisor will oversee quality assurance as it relates to overarching management of Site QA staff and compliance of the company processes and products in relation to established industry standards, specifications, and procedures, and to ensure the quality system is implemented and its integrity maintained.

ESSENTIAL FUNCTIONS

• Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.
• Manage and maintain an effective Quality Assurance program for the company in alignment with Corporate Operating Procedures and capable of maintaining regulatory certification status(es) as required.
• Review operating procedures to ensure compliance with all related procedures and instructions.
• Establish procedures and methods to comply with applicable GMP, USP requirements and customer expectations.
• Ensures timely resolution to customer inquiries (audit findings and complaints).
• Review customer requirements and make sure the system is in place to meet them.
• Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports.
• Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews.
• Conduct routine quality project management reviews with project teams and senior management.
• Drive continuous quality improvement projects at sites based on site data and customer expectations.
• Drive compliance to Corporate initiatives.
• Conduct Quality Management Review meetings of the company’s quality system.
• Establish and monitor Corporate Quality Metrics used to evaluate the effectiveness of the Quality

System.

• Oversee Site Quality Managers to assure knowledge and execution of Corporate Quality Systems.
• Assure proper use of change management associated with validated processes.
• Assure execution of internal audit program.
• Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification and customer requirements.
• Review data, analyze results and recommend changes based upon findings and perform follow up to verify effectiveness.
• Drive continuous quality improvement projects and Corporate initiatives.
• Utilize Corporate strategies and techniques to manage Time, and Budget for projects.
• Performs other related quality and management duties as assigned.

KNOWLEDGE-SKILLS-ABILITIES

• Physical Ability – The position is primarily sedentary.
• Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
• Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Speaking - Talking to others to convey information effectively.
• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Time Management - Managing one's own time and the time of others.
• Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making. Ability to train and be trained.
• Coordination - Adjusting actions in relation to others' actions.
• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
• Written Comprehension – The ability to read and understand information and ideas presented in writing.
• Written Expression - The ability to communicate information and ideas in writing so others will understand.
• Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.

TRAVEL

• Travel to SpectronRx sites is required.
• Travel requirement is 25% or as required by executive management.

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree is required or equivalent QA related work experience.
• Ten to fifteen years of QA experience in part 211 products, preferably with experience in biologics.
• Superior organizational and leadership skills with ability to help team grow and thrive.
• Experience with Customer interface and meeting customer expectations.
• Demonstrate team-building and problem-solving skills.
• Ability to effectively prioritize and escalate issues.
• Working familiarity with Project Management Tools and Quality Risk Management.
• Working knowledge of Pharmaceutical Industry requirements (cGMP, etc.).
• Ability to comply with the company’s safety policies at all times and enforce as necessary.
• Ability to comply with the company’s quality policies at all times and enforce as necessary.

ADDITIONAL REQUIREMENTS

• Possess a valid driver's license
• Pass a Background Check

ADDITIONAL INFORMATION/BENEFITS

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process.
• We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.

Job Type: Full-time

Pay: $95,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• We require ten to fifteen years of QA experience in part 211 products, preferably with experience in biologics for this position. Do you meet these requirements?

Education:

• Bachelor's (Required)

Experience:

• QA: 10 years (Preferred)

Work Location: In person